Status:
COMPLETED
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degree...
Eligibility Criteria
Inclusion
- Must have given written informed consent (signed and dated) and any authorizations required by local law.
- Willing to be confined to CRU for the entire duration required by the protocol.
- Male or female, between 18 and 80 years of age.
- Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
- Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
Exclusion
- Pregnant or lactating women.
- Treatment with another investigational drug or device within 30 days prior to study drug administration.
- Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
- Inability to swallow medication.
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
- Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03369002
Start Date
November 27 2017
End Date
May 15 2018
Last Update
May 18 2018
Active Locations (4)
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1
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
4
Vrg & Noccr
Knoxville, Tennessee, United States, 37920